Product Name & Strength: Fexet Tablet 180 mg, 2 x 10's in Alu-Alu blisters.
Indications (Approved Uses): Relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older, significantly reducing pruritus and the number of wheals.
Contraindications (Safety Warnings): Contraindicated in patients with known hypersensitivity to fexofenadine hydrochloride or any component of the product. Antacids containing aluminium and magnesium hydroxide reduce the absorption of fexofenadine hydrochloride and concurrent use should be avoided. Use during pregnancy only if the potential benefit justifies the potential risk to the foetus. Caution should be exercised when administered to nursing mothers as many drugs are excreted in human milk. Care should be taken in dose selection for geriatric patients due to the increased risk of toxic reactions in patients with impaired renal function, and monitoring renal function may be useful. Safety and effectiveness in paediatric patients under 6 years of age have not been established. While it is unlikely to affect the ability to drive or use machines due to lack of significant effects on central nervous system function, it is advisable to check the patient's individual response before driving or performing complicated tasks to identify particularly sensitive individuals who may experience an unusual reaction.
Side Effects (Adverse Reactions): Fexofenadine is generally well tolerated. Known side effects associated with its use include headache, drowsiness, nausea, vomiting, fatigue, and dizziness. Dizziness, drowsiness, fatigue, and dry mouth have been reported with overdose.
Nutritional Information (per tablet): Fexofenadine Hydrochloride 180 mg, Lactose Monohydrate 186 mg, Microcrystalline Cellulose (Avicel PH-102) 100.50 mg, Pregelatinised Starch 18 mg, Croscarmellose Sodium 33 mg, Purified Water, Pregelatinised Starch 30 mg, Croscarmellose Sodium 33 mg, Magnesium Stearate 4.5 mg, Hypromellose 5CPS (Methocel E-5) 8.775 mg, Titanium Dioxide 2.632 mg, Macrogols (P.E.G. 6000) 2.632 mg, Purified Talc.
Instructions for Use / Dosage: For oral/topical administration. For oral use. For seasonal allergic rhinitis in adults and children 12 years and older, the recommended dose is 60 mg twice daily or 180 mg once daily. For children 6 to 11 years, the recommended dose is 30 mg twice daily, with a starting dose of 30 mg once daily recommended for paediatric patients with decreased renal function. For chronic idiopathic urticaria in adults and children 12 years and older, the recommended dose is 60 mg twice daily, with a starting dose of 60 mg once daily recommended for patients with decreased renal function. For children 6 to 11 years, the recommended dose is 30 mg twice daily, with a starting dose of 30 mg once daily recommended for paediatric patients with decreased renal function. In adult patients with decreased renal function, the starting dose is 60 mg once daily.
Regulatory Information: NAFDAC Registration Number: A4-8790. Manufactured by: Getz Pharma (Private) Limited, Pakistan.
